This phase I trial studies how well [18F]DASA-23 and positron emission tomography (PET)/magnetic resonance imaging (MRI) scan work in evaluating pyruvate kinase M2 (PKM2) expression in patients with intracranial tumors or recurrent glioblastoma and healthy volunteers. PKM2 regulates brain tumor metabolism, a key factor in glioblastoma growth. [18F]DASA-23 is a radioactive substance with the ability to monitor PKM2 activity. A PET/MRI scan is a procedure in which a small amount of a radioactive substance, such as [18F]DASA-23, is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the substance is used. Tumor cells usually pick up more of these radioactive substances, allowing them to be found. Giving [18F]DASA-23 with a PET/MRI scan may help doctors evaluate PKM2 expression in healthy volunteers and in participants with intracranial tumors or recurrent glioblastoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03539731.
PRIMARY OBJECTIVES:
I. Determine whether the fluorine F 18 DASA-23 ([18F]DASA 23) PET scan signal change from pre-therapy to one week after initiation of therapy can predict the tumor’s responsiveness to therapy and 6-month progression-free survival (PFS6), in suspected recurrent glioblastoma.
SECONDARY OBJECTIVES:
I. Determine the sensitivity, specificity, and accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
II. Determine whether the [18F]DASA-23 PET scan signal change from pre therapy to one week after initiation of therapy can predict progression-free survival (PFS) and overall survival (OS), in suspected recurrent glioblastoma.
OUTLINE: Participants are assigned to 1 of 4 groups.
GROUP I: Healthy volunteers receive [18F]DASA-23 intravenously (IV) and undergo brain PET/MRI scan over 15 minutes and 4 vertex-to-toe PET/MRI scans over 30 minutes each.
GROUP II: Intracranial tumor patients receive [18F]DASA-23 IV and undergo brain PET/MRI scan over 60 minutes and 1 vertex-to-toe PET/MRI scan over 30 minutes.
GROUP III: Recurrent glioblastoma patients receive [18F]DASA-23 IV and undergo brain PET/MRI scan over 60 minutes. Patients undergo second PET/MRI scan 7 days after the initiation of therapy.
GROUP IV: Additional healthy volunteers receive [18F]DASA-23 intravenously IV and undergo brain PET/MRI scan over 60 minutes.
After completion of study treatment, intracranial tumor and recurrent glioblastoma patients are followed up every 3 months for 12 months.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorGuido Alejandro Davidzon